To Evaluate the Dose Response of 3 Doses of Euphorbia Prostrata in Patients With First and Second… (NCT01041911) | Clinical Trial Compass
CompletedPhase 2
To Evaluate the Dose Response of 3 Doses of Euphorbia Prostrata in Patients With First and Second Degree Hemorrhoids
India102 participantsStarted 2010-03
Plain-language summary
The purpose of this study is to determine the safe and efficacious dose of Euphorbia prostrata for control of per rectal bleeding in patients with first and second degree hemorrhoids.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adult subjects who are able to understand nature, significance and scope of the clinical trial and express their will accordingly and agreeing to participate in the study by giving written informed consent.
* Male or female subjects, at least 18 years of age with a diagnosis of internal hemorrhoids (first and second degree) confirmed by proctoscopic examination and suffering from an uncomplicated and untreated acute attack (defined as acute onset of per rectal bleeding within 3 days of inclusion into the study, with at least one of the symptoms viz. pain, tenesmus, pruritus and anal discharge).
* Except internal hemorrhoids (first and second degree), the subjects are judged to be in good general health, based on medical history, physical examination, and laboratory screening tests.
Exclusion Criteria:
* Pregnant and lactating women and women in post-partum period of up to 6 weeks.
* Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
* Subjects who have been previously enrolled in a study involving E. prostrata Dry Extract
* Subjects with a history of permanent anal prolapse and/or anal fistula
* Subjects with associated anal fissures and/or infective anal pathology.
* Subjects with previous history of surgery for anorectal disease (within 5 years) or any other procedures (including but not limited to injectio…
What they're measuring
1
Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject